Effects of Periodontal Treatment on HIV-infected Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-02

Study Completion Date

2019-04-08

Brief Summary

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Periodontal diseases, such as chronic periodontitis (CP), frequently occur in immunosuppressed patients, including HIV-infected patients. The immunosuppression resulted by the HIV infection can justify the high frequency and the difficult in controlling the CP in this group of patients, raising the possibility of additional factors associated to the development of CP in HIV patients. The aim of this study is to determine factors that can be involved in the CP pathogenesis in HIV patients, including Candida spp presence, and biomarkers involved on the inflammatory response against the microorganisms.

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Detailed Description

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Investigators will develop one quasi-experimental study in HIV patients (N=15) and non-HIV patients (N=15) presenting CP. Candida spp count and salivary and gingival crevicular fluid concentrations of histatin, lactoferrin, interleukin-1β, interleukin-6, and tumor necrosis factor-α will be determined at baseline, 30 and 90 days after the periodontal treatment. In order to minimize the influence of the immunosuppressive condition, patients have to present CD4 T lymphocytes \< 200cel/mm3 blood count, non-detectable viral load and the same protocol of antiretroviral therapy. Additionally, investigators intend to determine the immunophenotypic profile of the gingival tissue through immunohistochemical analysis. This study was approved by the Institutional Review Board of the School of Dentistry of Ribeirão Preto (CAAE: 50004415.1.0000.5419), and all patients need to provide written informed consent.

Conditions

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HIV/AIDS Periodontal Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HIV-infected group

Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.

Group Type EXPERIMENTAL

Basic periodontal treatment

Intervention Type PROCEDURE

Basic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments.

Non-HIV infected group

Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.

Group Type ACTIVE_COMPARATOR

Basic periodontal treatment

Intervention Type PROCEDURE

Basic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments.

Interventions

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Basic periodontal treatment

Basic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments.

Intervention Type PROCEDURE

Other Intervention Names

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Non-surgical periodontal treatment

Eligibility Criteria

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Inclusion Criteria

* General for both groups/arms: Patients with at least 15 teeth; with chronic periodontitis (at least 2 sites with pocket probing depth ≥ 5mm and clinical attachment loss \>4mm); no use of antibiotics for the 6 months previous to study enrolment.
* For HIV-infected group: CD4 T lymphocytes \< 200 cel/mm3, stable HAART for the 6 months previous to study enrollment.

Exclusion Criteria

* General for both groups/arms: periodontal treatment and use of antibiotics for the 6 months previous to study enrollment; smoking; complex systemic conditions.

Minimum Eligible Age

36 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes